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Medicare Beneficiary Guide to Durable Medical Equipment, Prosthetics, Orthotics, & Supplies (DMEPOS) PAGE 1 Originated February 22, 2016 | © 2016 Copyright, CGS Administrators, LLC. Table of Contents Introduction 2 Medicare Coverage - Benefit Categories 2 Durable Medical Equipment 4 Prosthetic Devices 4 Braces (Orthotics) 5 Surgical Dressings 5 Immunosuppressive Drugs 5 Therapeutic Shoes for Diabetics 5 Oral Anticancer Drugs 5 Oral Antiemetics (used as full replacement for IV form) 5 Intravenous Immunoglobulin for Primary Immunodeficiency (IVIG) 5 Physicians and Medicare - Who Is Considered a Physician? 5 Marketing and DMEPOS 6

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Page 1: Medicare Beneficiary Guide to DMEPOS · Medicare Beneficiary Guide to Durable Medical Equipment, Prosthetics, Orthotics, & Supplies (DMEPOS) ... Medicare Bene˜ciary uide to PAGE

Medicare Beneficiary Guide to

Durable Medical Equipment, Prosthetics, Orthotics, & Supplies (DMEPOS)

PAGE 1Originated February 22, 2016 | © 2016 Copyright, CGS Administrators, LLC.

Table of Contents

Introduction 2

Medicare Coverage - Benefit Categories 2

• Durable Medical Equipment 4

• Prosthetic Devices 4

• Braces (Orthotics) 5

• Surgical Dressings 5

• Immunosuppressive Drugs 5

• Therapeutic Shoes for Diabetics 5

• Oral Anticancer Drugs 5

• Oral Antiemetics (used as full replacement for IV form) 5

• Intravenous Immunoglobulin for Primary Immunodeficiency (IVIG) 5

Physicians and Medicare - Who Is Considered a Physician? 5

Marketing and DMEPOS 6

Page 2: Medicare Beneficiary Guide to DMEPOS · Medicare Beneficiary Guide to Durable Medical Equipment, Prosthetics, Orthotics, & Supplies (DMEPOS) ... Medicare Bene˜ciary uide to PAGE

Medicare Beneficiary Guide to

PAGE 2

Durable Medical Equipment, Prosthetics, Orthotics, & Supplies (DMEPOS)

Originated February 22, 2016 | © 2016 Copyright, CGS Administrators, LLC.

Introduction

CGS has provided quality, cost-effective services and technical solutions to the Centers for Medicare & Medicaid Services (CMS) for over 50 years, impacting the lives of over 24 million Medicare beneficiaries and over 100,000 health care providers and suppliers of medical equipment in 38 states. CGS is headquartered in Nashville, Tennessee.

CGS is the Jurisdiction B and C Durable Medical Equipment Medicare Administrative Contractor (DME MAC) providing services to the states of Alabama, Arkansas, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Michigan, Minnesota, Mississippi, New Mexico, North Carolina, Ohio, Oklahoma, Puerto Rico, South Carolina, Tennessee, Texas, U.S. Virgin Islands, Virginia, West Virginia, and Wisconsin.

CGS is also the Jurisdiction 15 A/B Medicare Administrative Contractor (MAC) providing claims payment and services for Medicare Part A and Part B for the states of Kentucky and Ohio and Home Health & Hospice services for the states of Colorado, Delaware, D.C., Iowa, Kansas, Maryland, Missouri, Montana, Nebraska, North Dakota, South Dakota, Pennsylvania, Utah, Virginia, West Virginia, and Wyoming.

In addition, CGS provides a full suite of support services for the Medicaid program, providing states with flexibility in offering health care for those in need while reducing overall program costs.

CGS is responsible for claim processing and policy development for 15 southeastern states and the territories of Puerto Rico and the US Virgin Islands.

Medicare Coverage – Benefit Categories

Your physician is familiar with Medicare benefit category restrictions related to preventive services. Coverage of DMEPOS is governed by statutory benefit categories. Unless an item or service falls under a specific benefit category, it is not covered by Medicare. For reimbursement determinations related to medical necessity or “reasonable and necessary” (Social Security Act §1862(a)(1)(A) determinations), the term “not medically necessary” is used.

Medicare Part B covered services processed by the DME MAC fall into the following benefit categories specified in the Social Security Act (§1861(s)):

• Durable medical equipment (DME)

• Prosthetic devices

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Medicare Beneficiary Guide to

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Durable Medical Equipment, Prosthetics, Orthotics, & Supplies (DMEPOS)

Originated February 22, 2016 | © 2016 Copyright, CGS Administrators, LLC.

• Leg, arm, back, and neck braces (orthoses)

• Artificial legs, arms and eyes, including replacement (prostheses)

• Home dialysis supplies and equipment

• Surgical dressings

• Immunosuppressive drugs

• Erythropoietin for home dialysis patients

• Therapeutic shoes for persons with diabetes

• Oral anticancer drugs

• Oral antiemetic drugs (replacement for intravenous antiemetics)

• Intravenous immunoglobulin for primary immunodeficiency (IVIG)

It is important to distinguish situations in which an item is denied because it is statutorily excluded or does not meet the definition of any Medicare benefit from those situations in which at item is denied because it is not reasonable and necessary (see below). Items denied due to statutory exclusion or for failure to meet a defined Medicare benefit result in payment liability for the beneficiary. Items denied for failure to meet medical necessity requirements (i.e., not reasonable or necessary) result in payment liability for the supplier unless there is a properly executed Advanced Beneficiary Notice (ABN). A properly executed ABN notifies the beneficiary that Medicare is not likely to pay for the item, includes the specific reason why Medicare will not pay and indicates that the beneficiary will be responsible for payment should Medicare not pay.

Some examples of statutorily excluded items or situations include, but are not limited to:

• Hearing aids

• Eyeglasses or contact lenses - except those provided following cataract removal or other cause of aphakia

• Durable medical equipment and related accessories and supplies provided to patients in nursing facilities

• Dental items

• Personal comfort items

• Orthopedic shoes or shoe inserts - other than those covered under the therapeutic shoes for persons with diabetes benefit or those that are attached to a covered leg brace

• Replacement of items that have not reached their useful lifetime and were not lost, stolen, or irreparably damaged (not including ordinary wear and tear)

Some examples of items or situations which do not meet the definition of a Medicare benefit include, but are not limited to:

• Parenteral or enteral nutrients that are used to treat a temporary (rather than permanent) condition Enteral nutrients that are administered orally

• Infusion drugs that do not require administration through a durable infusion pump

• Surgical dressings that are used to cleanse a wound, clean intact skin, or provide protection to intact skin

• Irrigation supplies that are used to irrigate the skin or wounds

• Immunosuppressive drugs when they are used for conditions other than following organ transplants Oral anticancer drugs when there is no injectable or infusion form of the drug or when used for a condition other than cancer

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Medicare Beneficiary Guide to

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Durable Medical Equipment, Prosthetics, Orthotics, & Supplies (DMEPOS)

Originated February 22, 2016 | © 2016 Copyright, CGS Administrators, LLC.

• Nondurable items (that are not covered under any other benefit category) - e.g., compression stockings and sleeves

• Durable items that are primarily and customarily used for a nonmedical purpose, even though the item may have some remote medically-related use - e.g., exercise equipment

• Items provided for the convenience of the beneficiary or caregiver

• Devices and equipment used for environmental control or to enhance the environmental setting are not considered covered DME

• Backup or precautionary equipment

General definitions and coverage issues relating to the preceding categories are described in greater detail below.

■ Durable Medical Equipment

Durable medical equipment (DME) is equipment which (a) can withstand repeated use, and (b) is primarily and customarily used to serve a medical purpose, and (c) generally is not useful to a person in the absence of an illness or injury, and (d) is appropriate for use in the home.

To be considered durable, the item must last at least three (3) years.

Supplies and accessories that are necessary for the effective use of medically necessary DME are covered. Supplies may include drugs and biologicals that must be put directly into the equipment in order to achieve the therapeutic benefit of the DME or to assure the proper functioning of the equipment.

Repairs, skilled maintenance and replacement of medically necessary DME are covered. Durable medical equipment is subject to reasonable useful lifetime limitations for replacement (typically five (5) years) unless the item is lost, stolen or irreparably damaged.

■ Prosthetic Devices

Prosthetic devices are items which replace all or part of an internal body organ or replace all or part of the function of a permanently inoperative or malfunctioning internal body organ. The test of permanence is considered met if the medical record, including the judgment of the treating physician, indicates that the condition is of long and indefinite duration (typically three months).

In addition to artificial arms and legs, coverage under this benefit includes, but is not limited to, breast prostheses, eye prostheses, parenteral and enteral nutrition, ostomy supplies, urological supplies in patients with permanent urinary incontinence, and glasses or contact lenses in patients with aphakia (loss of the natural lens(es) of the eye since birth) or pseudophakia (removal of the natural lens(es) of the eye due to cataracts or other diseases of the eye where the natural lens is removed).

Claims for internal prostheses (e.g. intraocular lens, joint implants, etc.) are not processed by the DME MAC. Claims for internal prostheses are the jurisdiction of the local A/B MAC contractors.

Supplies that are necessary for the effective use of a medically necessary prosthetic device are covered. Equipment, accessories and supplies (including nutrients) which are used directly with an enteral or parenteral nutrition device to achieve the therapeutic benefit of the prosthesis or to assure the proper functioning of the device are covered.

Repairs, adjustments and replacement of medically necessary prosthetic devices are covered.

Dental prostheses (i.e. dentures) are excluded from coverage.

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Durable Medical Equipment, Prosthetics, Orthotics, & Supplies (DMEPOS)

Originated February 22, 2016 | © 2016 Copyright, CGS Administrators, LLC.

■ Braces (Orthotics)

A brace is a rigid or semi-rigid device that is used for the purpose of supporting a weak or deformed body member or restricting or eliminating motion in a diseased or injured part of the body.

Repairs, adjustments and replacement of medically necessary braces are covered.

■ Surgical Dressings

Surgical dressings are therapeutic and protective coverings applied to surgical wounds or debrided wounds. Surgical dressings include primary and secondary dressings.

■ Immunosuppressive Drugs

Immunosuppressive drugs used in patients who have received a Medicare-covered organ transplant are covered. Immunosuppressive drugs used for indications other than transplantation are not in the DME MAC’s jurisdiction.

Supplies used in conjunction with parenterally administered immunosuppressive drugs are not covered under this benefit category.

■ Therapeutic Shoes for Persons with Diabetes

Custom molded or extra-depth shoes and inserts for use in persons with diabetes are covered under this benefit. This benefit is only for Medicare beneficiaries with diabetes. Medicare statute specifically excludes payment for shoes for any other conditions.

■ Oral Anticancer Drugs

Certain oral cancer drugs are covered if they have the same chemical composition and indications as the parenteral form of the drug.

■ Oral Antiemetics (used as full replacement for IV form)

Certain oral antiemetic drugs are covered when used as full replacement for the intravenous (IV) form of the same drug during chemotherapy treatment.

■ Intravenous Immunoglobulin for Primary Immunodeficiency (IVIG)

The Medicare Modernization Act of 2003 created a new benefit for IVIG administered in the home setting for persons with primary immunodeficiency. The benefit pays for the immunoglobulin only with statutory language specifically precluding payment for supplies and administration equipment (e.g., infusion pump, tubing, catheters, dressings).

Physicians and Medicare – Who Is Considered a Physician?

Physician means any of the following entities legally authorized to practice by a State in which he/she performs this function. The services performed by a physician within these definitions are subject to any limitations posed by the State on the scope of practice.

• Doctor of medicine;

• Doctor of osteopathy (including osteopathic practitioner) - must be licensed to practice medicine and surgery;

• Doctor of dental surgery or dental medicine;

• Chiropractor (see below);

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• Doctor of podiatry (see below) or surgical chiropody; and

• Doctor of optometry.

The term physician does not include such practitioners as Christian Science practitioner or naturopath. There is no Medicare benefit for DMEPOS items ordered by these entities.

Medicare coverage for all items and services furnished or ordered by chiropractors, with the exception of treatment by means of manual manipulation of the spine to correct a subluxation, is statutorily excluded. Therefore, all DMEPOS items ordered by chiropractors are denied as statutorily noncovered.

Medicare coverage for all items and services furnished or ordered by podiatrists is limited by State statutes governing the scope of practice for podiatry. DMEPOS suppliers should be familiar with the limitations imposed by the State statutes in which they operate and dispense DMEPOS items. Claims submitted to the DME MAC, when furnished or ordered by podiatrists practicing outside the limits of their licensures, will be denied as statutorily noncovered.

A nurse practitioner, physician assistant or clinical nurse specialist may order DMEPOS if all of the following conditions are met:

• They are treating the beneficiary for the condition for which the item is needed; and,

• They are practicing independently of a physician*; and,

• They bill Medicare for other covered services using their own provider number; and,

• They are permitted to do all of the above in the state in which the services are rendered.

(*Applies only to nurse practitioners and clinical nurse specialists. Physician Assistants must be practicing under the supervision of an MD or DO.)

Marketing and DMEPOS

Medicare regulations specifically address telemarketing to Medicare beneficiaries by medical equipment suppliers and pharmacies. There are only three circumstances where telephone solicitations are permitted:

1. The beneficiary has given the supplier written permission to make contact by telephone.

2. The phone contact involves a covered item that the supplier has already provided to the beneficiary.

3. The supplier has furnished at least one covered item to the beneficiary during the preceding 15 months.

If you feel that you have been approached by a medical equipment supplier or pharmacy in a manner that might be prohibited by Medicare rules and regulations, you may report this to 1.800.MEDICARE (1.800.633.4227). If you are hearing impaired or speech impaired, call the TTY/TDD line toll-free at 1.877.486.2048.